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Threshold Pharmaceuticals, Inc., a biotechnology company, discovers and develops therapeutic agents that target tumor cells for the treatment of patients living with cancer in the United States. Its lead investigational small molecule is evofosfamide, which is in two Phase III clinical trials for the treatment of soft tissue sarcoma indication and pancreatic cancer; Phase II clinical trials for treating non-squamous non-small cell lung cancer; Phase II clinical trials for advanced melanoma and soft tissue sarcoma; Phase I/II clinical trials for multiple myeloma and pancreatic cancer; and Phase I clinical trials for the treatment of solid tumors, pancreatic cancer, and advanced solid tumors. The company is also involved in the study of evofosfamide in investigator sponsored trials, including Phase I/II clinical trials for glioblastoma; Phase II clinical trials for glioblastoma and pancreatic neuroendocrine tumors; and Phase I clinical trials for advanced kidney cancer or liver cancer. In addition, it engages in developing antiangiogenic therapies in various tumor types in human clinical trials; TH-4000, an investigational hypoxia-activated EGFR tyrosine kinase inhibitor; and [18F]-HX4, an investigational PET imaging agent for hypoxia. The company has a license and co-development agreement with Merck KGaA to co-develop and commercialize evofosfamide; license agreement with Auckland UniServices Ltd. for the development program based on TH-4000; and license agreement with Eleison Pharmaceuticals, Inc. for the manufacture, development, and commercialization of glufosfamide for the treatment of cancer in humans and animals, as well as other uses. Threshold Pharmaceuticals, Inc. was founded in 2001 and is headquartered in South San Francisco, California.

threshold pharmaceuticals (THLD) Key Developments

Threshold Pharmaceuticals, Inc. Announces Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015

Jul 30 15

Threshold Pharmaceuticals Inc. announced consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company reported revenue of $3,680,000 against $3,680,000 a year ago. Loss from operations was $8,941,000 against $7,461,000 a year ago. Net loss was $8,306,000 or $0.12 basic and diluted per share against $766,000 or $0.12 diluted per share a year ago.
For the six months, the company reported revenue of $7,361,000 against $7,361,000 a year ago. Loss from operations was $18,556,000 against $16,067,000 a year ago. Net loss was $19,460,000 or $0.28 basic and diluted per share against $7,875,000 or $0.25 diluted per share a year ago.

Threshold Pharmaceuticals Inc. has announced encouraging preliminary data from the Phase II component of an ongoing Phase I/II trial of evofosfamide in combination with the proteasome inhibitor, Velcade, or bortezomib, and low-dose dexamethasone, or EBorD, in patients with relapsed/refractory multiple myeloma. A clinical benefit rate of 29% (one complete response, two partial responses, and one minimal response) was observed in patients treated at the recommended Phase II dose of evofosfamide (340 mg/m2) in EBorD. Objective responses were observed in heavily pretreated patients (median of 8 prior systemic therapy regimens) including prior treatment with bortezomib (median of 3 prior bortezomib-containing regimens). The ongoing Phase I/II trial is investigating evofosfamide and dexamethasone with or without bortezomib with respect to safety and tolerability, dose-limiting toxicities and the maximum-tolerated dose of evofosfamide, and preliminary efficacy in patients with relapsed/refractory multiple myeloma. The recommended Phase II dose of evofosfamide in EBorD was previously established at 340 mg/m2. A total of 25 patients with relapsed/refractory multiple myeloma have been enrolled in the EBorD component of the study as of May 1, 2015. Preliminary safety and tolerability results from the 18 patients included in the ASCO presentation support further investigation of evofosfamide in patients with relapsed/refractory multiple myeloma. The most common Grade 3/4 hematological adverse events were thrombocytopenia (reported in 11 patients), anemia (reported in 6 patients), and neutropenia (reported in 4 patients). Nausea (reported in 8 patients; one Grade 3/4) and fatigue (reported in 7 patients; one Grade 3/4) were the most common non-hematological adverse events. Eleven serious adverse events (SAEs) were reported in 9 patients. The only SAE occurring in more than one patient were two events of colitis. Neither event was considered related to evofosfamide. Five SAEs were considered as related to evofosfamide: bronchiolitis, melena, pneumonia, thrombocytopenia and viral infection. Skin toxicity and mucosal toxicities were not dose limiting. Rash was reported in five patients; stomatitis, skin lesion, pruritus and skin hyperpigmentation were each reported in one patient; none of these were Grade 3 or higher. No patients discontinued treatment due to an adverse event. There were no deaths related to study drug. Preliminary results from the 18 patients suggested anti-myeloma activity of EBorD therapy. According to modified International Myeloma Working Group (IMWG) criteria, responses included one complete response (CR), two partial responses (PRs), one minimal response (MR) and eleven stable disease (SD) assessments; three patients had progressive disease (PD). The patients with the CR and PRs had all previously undergone autologous transplantations and had received prior current standard treatment including IMiDs (a class of immunomodulators), proteasome inhibitors (including bortezomib), dexamethasone, and at least one conventional alkylating agent.

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